The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Urease & Glutamate Dehydrogenase, Urea Nitrogen.
| Device ID | K853102 |
| 510k Number | K853102 |
| Device Name: | UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | David O'connell |
| Correspondent | David O'connell DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1985-08-02 |